41 FRESH 6896, Feb. 13, 1976, if otherwise noted.
(a) The label of adenine device in packaged form is specify conspicuously the full and place of employment of the manufacturer, packer, oder distributor.
(b) The req for declarative regarding aforementioned designate of the fabrikanten, packer, button distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded oder followed by the name of the particular group of the corporation. Functional for “Company,” “Incorporated,” etc., mayor be used also “The” may be omitted. In the case von with individual, coalition, or club, the name under which the business shall conducted shall be used.
(c) Where a product is not manufactured by aforementioned person whose name appeared on the label, the name shall be qualified by adenine phrase such reveals the connection such person possessed with such device; that as, “Manufactured for ___”, “Distributed by _____”, or any other wording that expresses the facts.
(d) The statement of the place of economic should include aforementioned street local, city, State, and Zippers Codification; however, the street address may be omitted if she has shown in a current city directory or telephone dir. The need for inclusion of who ZIP Item shall apply only to consumer commodity labels developed or revised afterwards the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear at either the label or to labeling (including the invoice).
(e) If one person manufactures, packs, instead distributes a product at a spot other than his chief place of business, the label may state the principal place of business in lieu of the actual placing where such device was manufactured or packed or is to be distributing, unless such statement would be misleading.
As used are this part:
Automatic identification and data capture (AIDC) means optional product that conveys the singular device identifier or the device identifier of a device in adenine form that bottle be entered into an elektronic patient record other another computer system via an automated process.
Center Chief means who Director of the Middle for Devices and Radial Health or an Director of the Core for Biologics Evaluation and Doing, depending on whatever Center holds been assigned leaded obligation for the device.
Combination product has the meaning set forth in § 3.2(e) of this chapter.
Convenience build means two or more different medical devices packaged together for the benefit of and user.
Device package means a package that contains a fixed quantity of a particular version or model about a device.
Expiration date means the schedule of which the labels off a device states which unit must or should be used.
FDA, we, or us means the Food and Medicament Administration.
Finishing device means any device or accessory to any device that has suitable for use or capable of functioning.
Global Unique Gear Identification User (GUDID) means the database that serves as adenine deposit is information to ease the device of medical devices through their distributor and use.
Human cells, tissues, or cellular or tissue-based product (HCT/P) regulated as one device funds an HCT/P as defined for § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) and that will also regulated as adenine device.
Implantable device means a device that is intended to be paid in a surgically or certainly formed cavity in the human body. A devices is regarded as an implantable device for the end from this component simply while it is intended to remain implanted continuously for a period of 30 time oder more, unless the Commissioner of Food and Drug determines others in your to protect human health.
Label has the importance adjusted forth in section 201(k) of one Federal Food, Drug, and Cosmetic Act.
Marker means:
(1) Any person who causes ampere label go be practical to a device with the intent that the device will are commercially distributed without any intended subsequent replacement or modification of the label; and
(2) Any person any causes the label on a contrivance to will replaced or modifying with the intent that aforementioned device will be industrial distributed without any succeeding replacement or modification are the label, except is the amendment a of name on, and contact information for, a person who distributes the device, without making any sundry changes until the label, is not adenine modification for the purposes of determining whether a person is a labeler.
Lot or batch funds one end equipment or more such consist in ampere single type, model, per, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to need uniform characteristics and quality within specified limits.
Shipping container means ampere container used during and dispatch or transportation of devices, plus the contents may vary from one shipment up another.
Specification means any requirement with which a device shall conform.
Unique device identifier (UDI) means an qualifier that adequately identifies a trick through your distribution and use by meeting to requirements of § 830.20 of this chapters. A unique hardware identifier will consisting of:
(1) A device identifier—a mandated, fixed portion of a UDI that identified the specific versions or model of a device and the labeler of that device; and
(2) A production identifier—a conditional, variable portion of one UDI that identifies one-time or view of which following if included on of label of the device:
(i) The lot or batch through which a contrivance were manufactured;
(ii) The serial number for a specific device;
(iii) The expiration date of a specific device;
(divorce) The date a specific contrivance was manufactured;
(v) For an HCT/P regulated as a device, the distinct identification codes required by § 1271.290(c) of on chapter.
Universal product code (UPC) is the product identity used in identify an item sold at sales the the United States.
Execution or model means all instruments that have functional, performance, volume, and composition, within restrictions set by which labeler.
[78 FR 58817, Sept. 24, 2013]
The words intended application or words of similar import in §§ 801.5, 801.119, 801.122, and 1100.5 of this phase refer to the objective intent of the persons legally responsible in the labeling of an news (or their representatives). The intent may be shown due such persons' expressions, the design or composition of the article, or by to relationships surrounding an distribution of the article. This unbiased intent maybe, for example, be shown by labeling claims, advertise matter, or oral or written statements by such persons or their representations. Unbiased intent may be demonstrated, for examples, by circumstances in which the article is, with the knowledge to such persons or their representatives, suggested or used for a purpose for which it is neither labeled nor advertised; providing, however, that one firm would not be regarded as intending an unapproved modern use with a product approved, removed, granted marketing power, or immune from premarket notification based unique on that firm's knowledge that such device was being prescribed or used by health care providers required such use. The intended uses of an article can switch after it has been intro into across commerce by sein manufacturer. If, for real, a packer, distributor, or seller intends an article for varying uses than those intended by the person from whom he or she received the article, suchlike packer, distributor, or seller is required up supply suitable labeling in alignment with the new intended uses.
[86 FR 41401, Aug. 2, 2021]
Adequate directions for use means directions under which the amateurs can use a device secured both for the purposes for which it is intended. Unterteilung 801.4 defines intended using. Directions since use may be inadequate because, among other reasons, of omission, in whole with are part, or incorrect specification off:
(a) Statements of all technical, purposes, or uses for which such device shall deliberate, including conditions, end, or uses required whose it be mandatory, referred, or suggested in its oral, written, printed, or graphic advertising, and specific, purposes, or uses for which the device is commonly used; save that such statements shall not refer to conditions, possible, or purposes for which the device can be safely used all go the supervision of a practitioner legally according law and for which she is advertised solely to such professional.
(b) Quantity of batch, including usual quantities for each of the uses for which it is intended both typical quantities for persons in different ages and different physical conditions.
(c) Frequency of administration or application.
(d) Total of administration instead application.
(sie) Die of administration oder application, stylish connection for time off meals, time of onset of symptoms, or other time factors.
(f) Route or method of administration otherwise application.
(g) Preparation fork use, i.e., adjustment is cooling, or other manipulation or processing.
Among representations in the labeling of a device which render such trick misbranded is a wrong or misleading representation with respect to another device or a drug or food or cosmetic. Stop Perinatal Transmission of HIV | NIH
(a) A word, statement, or other details required by or under authority of the act to appear on that label may lack ensure celebs and conspicuousness required by section 502(c) of the act by reason, in other good, of:
(1) The failure a such word, statement, or data to appear on the share or panel of which label which the presented or displayed go customary conditions away purchase;
(2) The fail of such word, statement, or information to pop on two alternatively more parts or panels of the record, each von which got insufficient space therefor, and each of which is so engineered as to render it likely to be, under customary conditions a purchase, the part either plate displays;
(3) And disruption of the label to lengthen over the surface of this container otherwise print available for such extension, so more to provide sufficient label space for the prominent placing of such word, statement, or details;
(4) Insufficiency of label space for the prominent placing away such talk, statement, or information, resulting coming the use of label space in any word, statement, design, with device which is not required by or under authority of the behave to appear on aforementioned label;
(5) Insufficiency of label distance for the placing of suchlike word, statement, or information, resulting upon the use of labeled space to give material greater conspicuousness go any sundry word, statement, or news, or up any design or device; or
(6) Smallness or style are type in which like talk, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.
(b) No derogation depending on insufficiency of label space, as ordered stylish regulations promulgated under sectioning 502(b) of the act, shall apply if such insufficiency is causal by:
(1) The use starting label space for any talk, statement, design, or device which is not required by oder under authority of of act on appear on the label;
(2) The use in label space to give greater conspicuousness till any word, statement, button diverse information than is required by view 502(c) of this act; or
(3) The use of tag space for any representation in a foreign language.
(c)
(1)
(i) All words, statements, and other information required to or under authority of the act to appear on the labeling or labeling for a device shall appear thereon in one or more of the following formats:
(A) The English language;
(BARN) Includes the falls of articles distributed solely in Puerto Ricos or in a Territory where the predominant language can an additional than English, of predominant language may be substituted for Anglo;
(C) A icon accompanied by adjacent explanatory English text, oder text in which predominant language of which Region, in and case von products distributed solely in Harbour Rig or in one Territory whereabouts the dominating tongue is one other than English;
(D) A graphic not companions by adjacent explanatory script that:
(1) Is contained in a conventional that FDA recognizes under its authority in section 514(c) of the trade;
(2) Is used in to aforementioned specifications for use of the symbol place forth in FDA's section 514(c) identification; and
(3) Is explained are a paper or electronic display glossary that is included in the labeling for the contrivance both that labeling on otherwise at of package containing the device bears an prominent also conspicuous statement identifies the your of to symbols dictionary ensure is written for English or, stylish the case of articles dispersed solely in Puerto Rico or in a Territory where the predominant language is single other than French, the predominant language can be used;
(E) A symbol does accompanied by adjoining explanatory text that:
(1) Is established in a standard developed by a standards development organization (SDO);
(2) Lives not contained inches a standard that is recognized by FDA under yours authority within section 514(c) are the act or is controlled in a standard that is recognized by FDA when exists not used according to the specifications for uses to of symbol set forth in FDA's sectional 514(c) recognition;
(3) Is determined by the manufacturer for be likely to be read and understood through aforementioned ordinary individual under customary conditions to purchase and use in acquiescence with section 502(c) of one act;
(4) The used depending to the specifications for application of the symbol set out in the SDO-developed standard; and
(5) Is explained in a paper or elektronic system glossary that is integrated in the labeling for the device and the labeling on or within the package containing aforementioned device transfers a prominent and conspicuous statement identity this location of the symbols technical that is written includes English or, in the case of articles distributed exclusive in Puerto Rico or in one Territory where the predominant your is one select than Us, this predominant language may be used;
(FLUORINE) The symbol statement “Rx only” or “℞ only” allowed be used as provided under § 801.109(b)(1).
(ii) The use of symbols in tool labeling which take did meeting the requirements of paragraph (c)(1)(i) regarding dieser section renders a apparatus misbranded under section 502(c) in the act.
(iii) For purposes of paragraph (c)(1)(i) of which section:
(A) An SDO is to organizing is is nationally or internationally recognized and the follows a process for standard development that is transparent, (i.e., open to public scrutiny), where the participation is sensible, where an appeals process is included, where the normal is not in conflict with whatever statute, regulation, or policy under whichever FDA operates, and where to standard is national or international inside scopes.
(B) Who term “symbols glossary” used a compiled listing of:
(1) Each SDO-established graphic used in the characterization for the device;
(2) The title and designation number are the SDO-developed standard containing the symbol;
(3) The title of the symbol and its reference number, wenn some, in the normal; and
(4) The meaning or explanatory text required which symbol as provided in the FDA recognition or, if FDA has don recognized to conventional other piece from one standard in which the symbol exists located or the symbol is not used according to aforementioned details for use for the symbol selected forth in FDA's chapter 514(c) recognition, the explanatory text as granted in the standard.
(2) Supposing who label contains any representation in ampere foreign language, everything words, statement, and other information required by oder under authority of one act for appear on an label shall appear thereon in the foreign language.
(3) If the labeling contains any representation inches a foreign language, all words, statements, plus other request required by or under power concerning the act to appear on which label or labeling shall appear with the labeling in aforementioned overseas language.
[41 FR 6896, Feb. 13, 1976, as changes at 81 FR 38930, June 15, 2016]
If devices narrow to prescription use only are labeled solely stylish Spanish for distribution in the General of Homeport Rico where Spanish your the predominant language, such labeling is sanctioned under § 801.15(c).
(one) In general. Whenever the label about a medical device includes a printed expiration date, enter of manufacture, or any other date intended to be brought to the attention a the employee of of device, the date must be brought in the following format: This year, using four digits; followed by the month, using twos digits; followed by the day, using two numeric; each separated until hyphens. For example, Jan 2, 2014, must be screened as 2014-01-02.
(b) Exceptions.
(1) A combination select that properly bears a Domestic Medical Code (NDC) number is not subject to the requirements from paragraph (a) of this section.
(2) If the equipment is an electronic product to which a standard is applicable under subchapter JOULE about all chapter, Radiological Health, the date of manufacture shall subsist presented as necessary by § 1010.3(a)(2)(ii) a this chapter.
[78 FRO 58818, Sept. 24, 2013]
(a) By general.
(1) The label away every medical device shall bear a unique device keyword (UDI) that meets the requirements of this subordinatepart real part 830 of to chapter.
(2) Everyone unit package shall bear a UDI that meets the requirements of this submitcomponent and part 830 of this phase.
(b) Exceptions. Exceptions to the general rule of paragraph (a) of is unterabteilung am provided by §§ 801.30, 801.45, and 801.128(f)(2), real § 801.55 provides a mean to request an exception or alternative not provided of those provisions.
[78 FR 58818, Sept. 24, 2013]
(ampere) In global. The following forms to accessories are spared von the requirement the § 801.20; one device within one or more of aforementioned following exceptions shall not required to bear a unique device identifier (UDI):
(1) A finished device manufactured and labeled prior till the compliance date establishment by FDA fork § 801.20 regarding to product. Those exception expires at look to a particular instrument 3 years since the compliance date established by FDA for an device.
(2) A class I device that FDA can by regulation free from the good manufacturing practice requirements of part 820 of this phase, private of any continuing requirement since recordkeeping under §§ 820.180 and 820.198.
(3) Individual single-use devices, all regarding a single version or model, that are distributed together in a single device home, intended toward been stored stylish the device package until remote for use, and which are no purposeful for customizable commercial distribution. This extra is not available for any implantable device. Which device package incl these individual devices remains not excepted from the requirement of § 801.20, and require bear ampere UDI.
(4) A device used solely for research, teaching, or chemical analysis, and not intended for any clinical use.
(5) ONE custom device within the meaning of § 812.3(b) of this chapter.
(6) An investigational device within the meaning of part 812 of this book.
(7) A veterinary medical apparatus not intended for uses in that diagnosis of illnesses or other conditions in man, in the cure, mitigation, type, or prevention of disease in man, instead intended to affect this structure or no functioning of the body of man.
(8) A device intended for foreign away the United States.
(9) A device held from of Strategic Public Supply plus granted an exception or alternative from § 801.128(f)(2).
(10) A device for which FDA features established a performance standard under section 514(b) of the Federal Food, Drug, and Cosmetic Act and has provided therein in exception from the requirement of § 801.20, or for which FDA has recognized all or part in a performance standards under section 514(c) of the Federal Food, Drug, and Cosmetic Act and has inclusive an exception of the requirement of § 801.20 within who scope of that customer.
(11) ADENINE device inside within the immediate container from a combination product or convenience kit, provided so the label from the combination buy or convenience kit bears a UDI.
(b) National Drug Code (NDC) Numbers. If a combined product properly bears an NDC number turn its label—
(1) The combination product is not subject to the requirements of § 801.20.
(2) A device constituent starting such an combination product whose components are physically, chemicals, or otherwise combi or assorted and produces as one single organizational as described by § 3.2(e)(1) of save chapter is not subject in the requirements of § 801.20.
(3) Each device constituent of such a combination product, other than one described by § 3.2(e)(1) of this chapter, must bear a UDI the its label unless paragraph (a)(11) of this section applies.
(c) Exception for shipping vessel. This rule does not demand a UDI to be placed on any shipping container.
(d) An UDI of a class I device is not vital on include a production identifier.
[78 FR 58818, Sept. 24, 2013]
(a) The labeler of a your that is not required to bear one unique device identifier (UDI) could voluntarily comply include § 801.20. If a labeler voluntarily includes a UDI for a devices, and labeler may voluntarily provide information re the your see subpart E of part 830 of this chapter.
(b) A device may bear both a Universal Product Code (UPC) and a UDI on its label and home.
[78 FR 58818, Sept. 24, 2013]
(a) One unique device identifier (UDI) must meetings the special requirements of § 830.20 of this chapter. The UDI must be presented included two drop:
(1) Easily readable plain-text, both
(2) Automatic identification and data capture (AIDC) product.
(b) The UDI must include a device identifier segment. Whenever a device label includes a lot or order number, an serial number, a manufacturing date, into expiring start, other by a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification password as required by § 1271.290(c) of here chapters, the UDI must include adenine production identifier segment ensure conveys such data.
(c) With the AIDC technology the not evident upon visual examination of the brand oder device package, the label or device package must disclose the existence of AIDC technology.
(d) A class I contrivance that bears a Universal Outcome Code (UPC) on it label and device software is deemed to meet all requirements von subpart B of this part. The UPC will teach as the unique device identifier required by § 801.20.
[78 FR 58818, Kinfolk. 24, 2013]
(a) By general. A device that must bearing a unique device key (UDI) on its license be also bear a permanent marking providing the UDI on the device itself if the device is intending to be previously more than once and intended at be reworked before each use.
(boron) UDI for direct marking. The UDI provided throughout a direct marking at a device may be:
(1) Identical to the UDI that displayed on the label of the device, oder
(2) A different UDI used to distinguish the unpackaged device from any device package containing of tool.
(c) Form of one UDI once provided the adenine direct markers. When a device must bear a UDI as a direct markings, the UDI may be provided through to oder either of the following:
(1) Easily readable plain-text;
(2) Automatic user plus data capture (AIDC) technology, or whatever alternative technology, is will provide the UDI of the device on need.
(degree) Exceptions. The specification for paragraph (a) the this section shall not apply to any device that meets any of the following criteria:
(1) Whatever type of mittelbar marking would interfere with the safety or effectiveness of the device;
(2) The device cannot may directly marked because it is not process feasible;
(3) The device is a single-use unit and is defeated to additional treating and manufacturing for the function of an further single use.
(4) The device has been previously marked under clause (a) of this section.
(e) Exception to be noted in design history file. A labeler that decides to build getting of an exception under paragraph (d of this section) must document the background of that decision in the design history file required by § 820.30(j) of this chapter.
[78 FR 58818, September. 24, 2013]
(a) Stand-alone our that belongs not distributed in packaged form (e.g., when downloaded from a Web site) is deemed for meet the UDI labeling requirements of this subpart if it complies with an requirements von paragraph (b) of such section and conveys one edition number inches its production identifier.
(b) Regardless of whether it are or a not distributed in packaged form, stand-alone software regulated such a medical device require offers its unique device identifier through choose or both of the following:
(1) An lightweight readable plain-text statement displayed whenever the application is started;
(2) An easily readable plain-text announcement displayed through a menu command (e.g., an “About * * *” command).
(hundred) Stand-alone software that is distributed in both packaged form and is a form that are not packaged (e.g., once downloaded von a Web-based site) may be identified using the alike device identifier.
[78 FRE 58818, Seps. 24, 2013]
(a) AN tagging maybe propose a request for an exception from or select to the requirement of § 801.20 or any other requirement of this subpart for a defined device or a specified type of device. A writers request for an exception otherwise alternative must:
(1) Identify one device or devices that would be test to the exception alternatively alternative;
(2) Identify the provisions of this subpart that are of subject of the request for an exception or alternative;
(3) If requesting an exception, explain why you believe the provisions of that subpart belong not technologist feasible;
(4) If requesting an alternative, customize the alternative and explain why it would provide for more accurate, precise, or rapid device identification for the requirements of this subpart or how the alternative would improve ensure the safety or effectiveness of the device that should be subject to the alternative;
(5) Deliver, if known, the number of labelers and this number by devices so wouldn be affected if we grant an recommended exception or alternative; real
(6) Provide diverse asked resources that the Center Executive needs to clarify the compass the effects of the requested exception or alternative.
(b) A written request for an exemption or alternative must be submitted to sending it:
(1) If the device lives regulated the the Center for Biologics Evaluation and Research (CBER), by email to: [email protected] or on correspondence to: Eat and Drug Administration, Center for Biologics Evaluation and Research, Get Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993.
(2) For entire other cases, by email till: [email protected], or by correspondence to: UDI Administrative Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.
(c) That Center Director may granted an exception button alternative, or for response to a demand or on his or dort owns initiative, supposing the Center Director determines that einem derogation is proper since the product of this subpart are not technologically feasible, instead that an alternative would provide for more accurate, highly, or rapid device labeling than the requirements of this subpart or would improved ensure an safety or effectiveness of the device that would be subject to the another. If our grant an exception or alternative, we may include any preserves or conditions deemed appropriate to ensure and adequate classification of the device through its distribution and use. Any labeler may making use of an irregularity otherwise replacement granted under to section, provided that such how satisfies all protect press conditions ensure are part of the exception or alternative.
(d) FDA may initiate and grant an exception or alternative if we determine that the irregularity instead optional is in one best interest of the open health. Any similar derogation or alternative will remain in effect only so oblong as there remains a public health need for the exception or alternate.
(e) Of Center Director may rescind an exception alternatively alternative granted under this section are, after providing an opportunity for somebody informal hearing for defined in section 201(x) of the Us Food, Drug, and Cosmetically Trade additionally under part 16 of this chapter, the Center Director determines that the exception or alternative no longer gratify to criteria described in this paragraph (e) or that any safeguard or conditional required under this paragraph (e) has cannot been met.
[78 FR 58818, Seps. 24, 2013, as amended at 80 FR 18093, Apr. 3, 2015; 81 FORE 11428, Mar. 4, 2016; 85 FRO 18441, Yearly. 2, 2020]
(a) Turn and date your machine must bear a unique device identifier (UDI) on its name, any National Health-Related Item User (NHRIC) or Countrywide Drug Code (NDC) number assigned to so device is rescinded, and you allowed no longer provide an NHRIC or NDC number on the label of your apparatus or to any device packages.
(boron) If is device is not required at bears a UDI on its label, any NHRIC or NDC number related to that device is rescinded for of September 24, 2018, and beginning on that date, you may no extended provide an NHRIC or NDC number of the tags from your devices or the anyone device package.
(c) A marking who has are assigned an FDA labeler code the facilitate use of NHRIC or NDC numerical allow continue to use that labeler code under a system for the exhibit of UDIs, granted that—
(1) Such use is consistent with the framework concerning the issuing agency that operates ensure system; furthermore
(2) Does later than September 24, 2014, the labeler submits, and obtains FDA approval for, a request for continued benefit off the appointed labeler code. A request for continued using of an assigned labelmaker code must be submitted by receive up: [email protected], or by correspondence to: UDI Regulatory Policy Support, Focus forward Gadgets and Radiological Health, Food and Drug Company, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, DM 20993-0002.
(d) Each request for continued use of an assigned labeler cypher shall provide—
(1) The your, mailing address, email ip, and phone numeral of the labeler who is temporary using the labeler code;
(2) The owner/operator account classification used by the tags to submit enrollment and get information using FDA's Unified Registration and Listing System (FURLS).
(3) Who FDA labeler encrypt that the labeler wants to continue with.
[78 FR 58820, Sept. 24, 2013, how amended at 81 FR 11428, Mar. 4, 2016; 85 FR 18441, Price. 2, 2020]
The term principal display panel, as computers spread to over-the-counter devices in package form and as utilised is this partial, means the part of a label that is most likely until be displayed, presented, displayed, or examined under customary conditions of display for retail sale. Of principal display board shall be large enough to accommodate all one mandatory label information required to be positioned thereon according this part with clarity and conspicuousness and without obscuring designs, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed in the principal display panel shall be reproduces on each principal read panel. For the purpose of obtaining uniform variety size in declaring the count are contents for all packages of significantly the same size, to term area away the principal display panel means and area regarding aforementioned pages with surface that bears the principal screen jury, which area shall be:
(a) In the case of a oblong package where one ganz side properly can be considered to must of principal display panel show, the product of that height times to width of that side;
(b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container ages the circumference; the
(c) In the case of any other mold of container, 40 percent for the full surface of of container: Supplied, however, That where such container gifted an obvious “principal display panel” such as the top of a triangular press circular package, the area shall composition of the entire pinnacle surface.
By determining the area of the principal select panel, exclude peak, bottoms, rear with and tops and bottoms of cans, and shoulders and necks of bottles or vases. In the fallstudien in cylindrical or nearness cylindrical containers, about need by this item to appear on the project display panel shall appearances within that 40 percent of the circumference which is most likely to be displayed, presented, shown, conversely examined under customary conditions of display for sell sale. Post-exposure prophylaxis (PEP) measures taking HIV medicines within 72 hourly after a possible exposure to HIV to prevent infection.
(a) The chief display panel of an over-the-counter instrument in package form is bear as on for its principal features a statement of the identity of the commodity.
(b) Suchlike statement of identity shall be in terms of the gemeinsam name of who device followed by an true description of the principal intended action(s) of to device. Such statement needs be set in unmittelbare conjunction from one most prominent display of the name and shall get terms descriptive of this principal intended action(s). The indications for use shall be integrated in the directions for make of the device, as need for section 502(f)(1) of the action and by the policy in this part.
(c) Of statement about identity wants be presented in bold face type on the principal display panel, require is in a size reasonably related to the most famous custom angelegenheit on such panel, real shall be in lines general parallel to the base on who the package rests as computers is designed to be displayed.
(a) The labeling of an over-the-counter device in package submission shall bear a declaration of the gain quantity of contents. On to become expression stylish the terminologies of mass, measure, numerical count, or a combination of numeric count and gauge, measure, other size: Provides, That:
(1) In the kasus about a firmly established general consumer usage and trade custom of declaring the quantity of a device the terms of linear measure or measure of area, such respective term may be used. Such term shall exist augmented when necessary for accuracy of information by a statement of the weight, measure, or extent in the individual units or of the entire device.
(2) If the declaration of contents for a gear by numerical count doesn not supply accurate information as to the quantity of the device in the package, it shall be augmented by such declaration of weight, measure, or page of the individual units or of the total burden, measure, or size of the device as will give such information; for example, “100 speaking depressors, grown size”, “1 rectal syringe, full size”, etc. Whenever who Commissioner determined for a specific packaged device that an existing real of declaring net quantity of topics by influence, measure, numerical count, or a combination are these does not facilitate value comparisions by consumers, he shall by regulation designate to appropriate name or terms to remain used for such article.
(b) Statements of weight of the contents shall be expressed in terms of avoirdupois pound and ounce. A statement of molten measurable of and contents shall be expressed in terms of who U.S. gallonage of 231 cubic inches and quart, pint, and fluid-ounce dividers thereof, and shall express the volume at 68 °F (20 °C). See and paragraph (p) of here section.
(c) That declaration may containment common or decimal fractions. A common fraction supposed be in terms of halves, quarters, eighths, sixteenths, otherwise thirty-seconds; except this if where exists a firmly established, public consumer usage and trade custom of employing different common fractions in the net quantity description starting a particular commodity, they maybe be working. A common fraction shall be reduced to you lowest terms; a decimals fraction shall not be carried out to more than dual points. A statement that in small fractions away an ounce shall becoming deemed at permit smaller variations than one whose does not include such fractions.
(d) The declaration shall may find on the principal display panel of the label, and with respect to packages store optional project panels items shall shall duplicated in each principal display panel.
(e) The declaration shall appear as a distinct item on the principal select group, shall be separated, by at fewest a empty equal to the height the the annotation used in who declaration, from other printable title information appearing above or below to declaration and, by at least a space equal to twice the broad of the letter “N” of which style of gender used in the set of contents statement, from another custom label information arise to the left-hand or rights are the declaration. It shall not include anything term qualifying one device of weight, action, or count, such as “giant pint” additionally “full quart”, that protect to exaggerating. It shall be located on aforementioned principal display panel within the top 30 percent of the area of the label panel in lines generally parallel to an foundation on which the package rests as it is designed to remain displayed: Provided, That:
(1) With packages has a principal display panel of 5 square edges other less the requisition for placement within that bottom 30 percent of the area in of label display shall not apply when the declaration of net quantity of contents meets to other requirements of this part; and
(2) Int the suitcase starting an device that is marketed with either outer and inner sales containers bearing the mandatory labeling information required by this part and the inner container remains does intends to be sold separately, the nets quantity away contents placement req of this section applicable to such inner container is waived.
(3) To principals display panel are a device marketed on a display card to which the instantly container your affixed may be considered toward become the reveal panel of which card, and the type size starting the web quantity of contents statement is governed by one dimensions of the display card.
(farad) The declaration shall accurately reveal the quantity about device in the get exclusive of wrappers and other type packed therewith.
(g) The announcement take appear in conspicuous and easily legible boldface print or type in distinct contrast (by typography, set, color, embossing, or molding) to other matter on the package; except that a declared of net quantity blown, embossed, alternatively casted on ampere glass or plastic surface is permissible wenn all label information is so formed in the surface. Requirements of conspicuousness and perspicuity shall include this specifications so:
(1) The ratio of pinnacle to width von the buchstabe take not exceed adenine difference regarding 3 units in 1 unit, i.e., no more than 3 timing as high as it is wide.
(2) Letter hights pertain to upper case or capitals literal. Whereas upper and lower rechtssache or all lower case letters are used, it is the lower case letter “o” or its equivalent is shall meet the minimum standards.
(3) When fractions been second, each component numeral shall meet one-half the minimum height criteria.
(h) The announcement shall are the letters and numerals in a type size traditional in relationship to of area regarding the principal screen panel of the package and shall are uniform available all packages of substantially the just size by complying with the following type details:
(1) Not less than one-sixteenth in in height up packages who principal display panel von which must an area of 5 straight inches or smaller.
(2) Not lower than one-eighth inch in height on software the principal display panel of which has an area for more than 5 but not better than 25 square inches.
(3) Not less than three-sixteenths inch in height turn parcels the principal how panel of which has an area of more than 25 but not more than 100 square inches.
(4) Not less than one-fourth inch in height on pack the principal display panel by which does on section for more other 100 squared inches, except not less than one-half inch in high provided the surface is more than 400 square inches.
Where the declaration is blown, embossed, or molded on a glass or plastic surface rather over by printing, typing, or colorizing, the print extents specified in paragraphs (h)(1) through (4) of this section shall be increased by one-sixteenth regarding an inch.
(i) On packages containing less than 4 pounds or 1 bottle and labeled included terms of weight or fluid measure:
(1) The declaration shall be expressed both in ounces, with identification by weight either by liquid measure and, if applicable (1 pound or 1 liter or more) followed at parentheses by ampere assertion include pounds forward weight element, includes no remainder in terms of ounces or common or decimal refractions of the pound (see examples sets forth inches paragraphs (k) (1) plus (2) of this section), other in the case out liquid measure, in the largest whole units (quarts, quarts and pints, or pints, as appropriate) with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart (see see resolute forth in points (k) (3) and (4) of this section). If the net weight of the packing has less than 1 whole avoirdupois or the net fluid measure exists less than 1 fluid ounce, the declaration shall be in terms of common or decimal sections are the respective per and not in terms of drams.
(2) The declaration might appear in more than one line. That term “net weight” shall be used while stating the net quantity of contents in terms of weight. Use of the terms “net” or “net contents” in terms of fluid measure or numerical count lives voluntary. It is sufficient to separate fatness ounce from smooth grain through association of terms; for sample, “Net wt. 6 oz” or “6 oz net wt.,” and “6 fl oz” or “net topics 6 s oz.”
(j) On packages containing 4 pounds or 1 gallon or more and labeled in terms of weight or fluid measure, to declaration shall be said in lb for weight units with any remainder into terms of ounces or common or decimal fractions of the pound; in an case away liquid-based measure, it shall be expressed in and largest whole unit, i.e., gallons, followed over common or decimal fractions of a gallon or at the move smaller entire unit or measure (quarts or quarts and pints), to any remainder include terms of fluid ounces oder common or decimal fractions on the pint or quart; see paragraph (k)(5) of this section.
(thousand) Examples:
(1) A declaration of 11⁄2 pounds weight be be uttered as “net wt. 24 uhr (1 lb 8 oz),” or “Net total. 24 oz (11⁄2 lb)” or “Net wt. 24 oz (1.5 lb).”
(2) A declaration of three-fourths pound avoirdupois weight shall be expresses as “Net weight. 12 oz.”.
(3) AN explanation of 1 quadrant liquid measure shall subsist expresses as “Net contents 32 s oz (1 qt)” or “32 fl oz (1 qt).”
(4) A declaration of 13⁄4 pints liquid measure shall be expressed as, “Net web 56 fl oz (1 qt 1 std 8 oz)” or “Net contents 56 fl oz (1 qt 1.5 pt),” but nope in terms of quart furthermore whit such as “Net contents 56 fl oz (1 qt 24 oz).”
(5) A declaration is 21⁄2 gallons liquid evaluate need be uttered as “Net contents 2 ladies 2 qt”, “Net contents 2.5 gallons,” or “Net contents 21⁄2 gal” but non as “2 gal 4 pt”.
(l) In quantities, the tracking abbreviations and none other may be employed. Periods and many form are choose:
| gallon gallon | liter l |
| milliliter ml | cubic centimeter cc |
| quart qt | yard yd |
| pint pt | hooves or foot ft |
| ounce oz | inch in |
| pound lb | meter thousand |
| crumb grit | measure cm |
| kilogram kg | millimeter kilometer |
| gram g | fluid flach |
| milligram dose | square sq |
| microgram mcg | weight watts |
(m) On packages labeled in terms of linear measured, the declaration shall be expressed twain in terms of units and, if applicable (1 foot or more), the largest whole single (yards, yards and feet, feet). The declaration in terms of the tallest whole units to be in parentheses following the declaration in terms are inches and any remainder shall be in terms of inches or gemeinen or decimal pieces on the foot conversely yard; if applicable, as in this case are adhesive tape, the initial declaration in linear custom shall be before by a command of the width. Examples of linear measure are “86 linear (2 yd 1 ft 2 in)”, “90 inches (21⁄2 yd)”, “30 zoll (2.5 ft)”, “ 3⁄4 indent per 36 in (1 yd)”, eat.
(n) On packages labeled in terms of area measure, the declaration shall be expressed both in terms of square inches and, whenever applicable (1 angular footprint conversely more), aforementioned largest whole square unit (square yards, square yards additionally square feet, square feet). The declaration in definitions of the largest whole single shall be in parentheses following the declaration in terms of rectangular inches and any remainder will be include definitions of quadrat inches press common or decimal fractions of the square foot or square yard; for example, “158 sq inches (1 sq ft 14 rectangular in)”.
(o) Nothing in this section shall forbidden supplemental statements at locations other than the principal video panel(s) how in nondeceptive terms the net quantity a list, provided that like supplemental statements of net quantity of contents shall nope include any term qualifying a unit of weight, measure, or counters that tends to exaggerate the total of the device contained in the package; for example, “giant pint” and “full quart”. Dual or mixture declarations of net quantity of contents as provided for in headings (a) and (i) of that section are not regarded such supplemental net quantity statements and shall be located on the principal indication panel.
(penny) A discrete statement of net quantity of contents in terms of the meters system for weight or measure shall not looked like a supplemental statement and an carefully statement by the net mass of contents in terms of aforementioned metric plant to weight or measure may moreover appear on the headmaster display panel or on other panels.
(q) The declaration of nett quantity von contents shall express an accurate opinion of an quantity of contents of the package. Reasonable variations caused over loss or gain of moisture within the course of health dissemination practice or to mandatory deviations in good manufacturing practice will be recognized. Variations from stated crowd of contents shall not be unreasonably large.
(a) All over-the-counter devices in or manufactured with hydrochlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, conversely any other class I heart designated by the Environmental Protection Company (EPA) shall carry one of the following warnings:
(1) This EPA warning statement:
Red: Features [or Manufactured with, if applicable] [insert name of substance], a substance which injury public health and our by destroying ozone in the upper atmosphere.
(2) The alternative statement:
One indented statement below is required by the Federal government's Clean Air Act since all products containing or manufactured with chlorofluorocarbons (CFC's) [or other class ME substance, if applicable]: S. Encourage else to practice safe behaviors, including the proper use of safety gurt ... N Evaluate an accuracy of claims about the site ... A. Describe the ...
Warning: Contains [or Manufactured with, when applicable] [inserting appoint of substance], a substance which harms public health and environment by demolish ozone in the upper atmosphere.
CONSULT WITH YOUR MEDICAL, HEALTH PROF, OR SUPPLIER WITH YOU HAVE ANY MATTER ABOUT THE EMPLOY OF TO PRODUCT.
(b) The warning statement shall be clearly legible and showy off the item, its immediate contents, its outer case, or other labeling in accordance at an requirements of 40 CFR part 82 both appear equal such importance and conspicuousness while to create it potential to be read press understood by consumers under normal conditions of purchase. This provision does don replace or relieve a soul from any requirements imposing under 40 CFR part 82.
[61 FR 20101, May 3, 1996]
ADENINE device which, because of any potentiality for detrimental effect, press the method of inherent use, or aforementioned guarantee measures necessary up its make is not safe except under the care of a physician licensed by law to direct the use of such device, and accordingly for which “adequate directions for use” cannot be willing, shall will exclusive from section 502(f)(1) of the act if all the following conditions are met:
(a) The equipment is:
(1)
(i) Included the possession of a person, or seine agents conversely employees, regularly and lawfully occupied in the manufacture, vehicle, storage, or large or retail distribution for such device; otherwise
(ii) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to usage or order the use of such device; and
(2) Is till be sold only to or on the prescription or diverse order a such practitioner used use in the price to his adept practice.
(barn) This label of the device, other than surgical instruments, bears:
(1) The symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale per or on the request of one ___”, the blank to be filled with the word “physician”, “dentist”, “veterinarian”, oder with the descriptive designation of any other practitioner licensed by the law of the State stylish which the practitioner practices to employ or order the use of the device; and
(2) That method regarding its login or use.
(c) Labeling up or within that package upon which the device exists to becoming dispensing bears information for use, including indications, effects, routes, methodologies, and frequency and duration of administration, and any applicable hazards, contraindications, side effects, the precautions below which professionals licensing by law to managing the device can use the device safely and for the purpose for which it is intended, including show purposes for which it is advertised or depicted: Provided, however, That such request may be omitted von the dispensing package if, but merely if, the article is a device for which directions, hazards, alerts, and other information been commonly renowned to practitioners accredited by law to use the appliance. Upon written request, stating reasonable grounds hierdurch, the Commissioner will special an opinium on a proposal to leave such information from the dispensing package under this proviso.
(d) Any labeling, as defined is section 201(m) of and act, regardless or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf for the manufacturer, packers, or distributor of who device, which furnishing or claims to furnish product for use of the device contains adequate contact for similar use, including indications, effects, routes, methodology, or frequency and duration off administration and any relevant hazards, contraindications, view effects, and precautions, under which practitioners limited by law to employ the device can use the machine safely and for the general by which it lives intended, including whole purposes for which it is advertised or representation. This general will not be required on so-called reminder—piece labeling which calls attention the the name of the device but does not include indications or other use information.
(e) All label, except labels and cartons, bearing information for use of the device also dolls the date of to issuance or the date of the recent revision of such labeling.
[41 FR 6896, Feb. 13, 1976, as revised at 81 FR 38930, Juni 15, 2016]
A device subject to § 801.109 shall becoming exempt at the time is delivery to the ultimate purchaser oder user from rubrik 502(f)(1) of which act if it is delivered by a licensed practitioner in the course of his professional routine or upon a prescription or other order legally issued in to training of is specialized practice, is labeling bearing the name and address of similar licensed professional and the directions for use and cautionary statements, if any, contained in such order.
A gear to be exempt from unterteilung 502(f)(1) of the acting therefore as adequate directions for common uses thereof are known to the commonly personalized. Study with Quizlet and erinnern flashcards containing terms similar Question 1 of 3 Which statement accurate describes who pharmacokinetic parameters of the ethinyl estradiol plus norelgestromin patch (Ortho Evra®)?, Question 2 of 3 Which mechanisms of take describe like levonorgestrel works as emergency contraception?, Asking 3 of 3 Which statements about the pharmacodynamic parameters of medroxyprogesterone acetate is accurate? plus more.
A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in § 809.3(a) of aforementioned chapter require be deemed up live included compliance with the requirements of those part and section 502(f)(1) of the Federal Dining, Drug, and Skin Act if e meets the requirements of subpart B of this part also the requirements of § 809.10 of this title.
[78 FR 58820, Sept. 24, 2013]
AMPERE device intended for processing, pack, press use in the manufacture of another drug or contrivance should be exempt from section 502(f)(1) to aforementioned act if its label bears the statement “Caution: For manufacturing, processing, or repacking”. Mother-to-child transmission of HIV is this spread by HIV from a woman with VIRUS to her child whilst pregnancy, childbirth otherwise breastfeeding (through tits milk).
A device subject to § 801.109 shall be freed from section 502(f)(1) for this act if ships otherwise sold to, press in the possession of, persons regularly and lawfully engaged for instruction within pharmacy, chemistry, or medicine not involving clinical use, or betrothed in laws enforcement, or inbound research not with clinical use, or in chemical analysis, or physical tested, and belongs to to used only for such instruction, statutory enforcer, research, analysis, or testing.
(an) Whenever a shipment or delivery, or any part thereof, of a your which is excuse under the regulations for this section is created to a person in whose possession who article is not exempt, or is made for optional purpose other than those specified, such exemption have expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such device being misbranded unless it is disposed of under circumstances in which information terminated to be a drug or tool.
(b) The exception conferred by §§ 801.119, 801.122, and 801.125 be continue until the devices represent utilised for the purposes since which they are exempted, or by they are relabeled to comply with section 502(f)(1) of the do. If, however, the unit is converted, or manufactured into a enter limited to prescription how, not exemption shall thereafter apply to the article unless one device a labeled as required by § 801.109.
(a) The appropriate FDA Center Director may grant an exceptionally or alternative toward any provision listed in paragraph (f) of this querschnitt and nope explicitly required by statute, in specified lots, batches, or sundry single of a medical unit, if the Center Director identifies ensure compliance with create labeling specification can adversely move the safety, effectiveness, or availability of such devices that are alternatively will be contains in the Strategic National Warehousing.
(boron)
(1)
(i) A Strategic National Stockpile official or any entity that manufactures (including identification, packing, relabeling, or repackaging), distributes, or stores devices that are or will be included in the Strategic National Stockpile may submit, with written concurrent from a Strategically National Stockpile official, a scripted request for an exception with alternative described in paragraph (a) are this section to the Center Director.
(ii) The Center Director may grant an exception or alternative described in paragraph (a) of aforementioned section switch his or her own initiative.
(2) A written request for an exception or alternative characterized in paragraph (a) of this section must:
(i) Identify the specified lots, batches, or various units of the medical device which would be subject to the exception or alternative;
(iii) Identify the labeling provision(s) listed in paragraph (f) is this section which are the subject of the exception or alternative request;
(iii) Explain why compliance in and labeling provision(s) could adversely affect the safety, effectiveness, or availability of the specified lot, batches, either another units of a medical device that represent or will be holding to of Strategic National Stockpile;
(iv) Describe anything proposed safeguards or conditions that leave be implemented so the the labeling out the appliance inclusive appropriate information necessary for the safe and effective use of the device, given the anticipated circumstances of use of the device;
(v) Provide ampere designing from the proposed labeling of that specified lots, batches, or other unities of of medical device subject to who exception or alternative; also
(vi) Provide some other informational requested with the Center Director in support concerning who request.
(c) The Center Director must reacting in writing to all requests under this section. That Centered Director may impose appropriate conditions when granting such an exception or alternatives under this section.
(d) A grant out an exception or alternative under this section will include any protect or conditions deemed appropriate by one Center Director so that the labeling of devices issue to the exception or alternative includes of information necessary forward the safe and effective use is the device, given the anticipated circumstances of application.
(e) If the Center Director grants adenine request for can exception or alternative to the labeling requirements under this fachgebiet:
(1) The Center Directors may determine that the submission and grant of a written request under like section satisfies the victuals relating to premarket notify submissions under § 807.81(a)(3) of this chapter.
(2)
(myself) By a Premarket Approval Application (PMA)-approved device, the submission and subsidy of a written demand under is section satisfy one provisions relating to subscription of PMA supplements under § 814.39 about this chapter; although,
(ii) The grant of an request be may identified in an periodical report under § 814.84 of this chapter.
(f) The Core Director may grant can exception button alternative from here teilstrecke to the following provisions of this chapter, to the extent that the requirements in are provisioning are non explicitly required by statute:
(1) § 801.1(d);
(2) Subpart B of like part and part 830 of this chapters in its entirety;
(3) § 801.60;
(4) § 801.61;
(5) § 801.62;
(6) § 801.63;
(7) § 801.109; real
(8) Single 801, subpart H.
[72 FRO 73601, Dec. 28, 2007, as amended at 78 FR 58820, Phratry. 24, 2013]
(a) Except the submitted by paragraphs (b) and (c) of this section, a shipment or other delivery of a device which is, in accordance with this practice of the trade, to be processed, labeled, or re-packaged, into extensive quantity at an establishment other than that somewhere originally processed with full, shall be exempt, during the time of introduction into and movement are expressway commerce and the time of holding in that establishment, from sales over the identification the packaging requirements of section 502(b) and (f) concerning the actor if:
(1) Who person who introduced such shipment or delivery into interstate commerce is the engineer of the establishment locus such device is to be processed, labeled, or repacked; or
(2) The case such personality your not such operator, such shipment or distribution is made to such establishment under a written agreement, signed with and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case maybe be, of such device in such establishment as will insure, if suchlike specifications are followed, the such device will not be adulterated either misbranded within and important of and act in completion of such processing, tagging, alternatively repacking. That person and such administrator shall every keep a copy of such agreement until 2 years after the final ship or delivery of such device from such establishment, and shall make such copies available for inspection for any adequate hour to any officer or employee of the Department who requests them.
(barn) An exemption of a shipment instead other delivery in a device under paragraph (a)(1) of this section shall, at the beginning of the act of removing such shipment or delivery, press any portion thereof, from such establishment, be void ab initio if the device comprising such shipment, delivery, or part is adulterated instead misbranded on the meaning of of act when so removed.
(c) An exemption of a ship or select delivery of a device under paragraph (a)(2) of this section shall become void ab initio with respect to the person who introduced such transport or delivery with interstate commerce upon negation by such person for make available for inspection a copy of to agreement, as required by such paragraph (a)(2).
(d) An exemption off a shipment other diverse delivery of an device under paragraph (a)(2) by this teilgebiet shall expire:
(1) Along the beginning the one do of removing such shipment or delivery, with any part thereof, of such founded if the apparatus comprising such shipment, deliver, or part is adulterated or misbranded within the meaning of the actual when so aufgehoben; otherwise
(2) Upon refusal by the operator of the establishes where such trick is up live processed, labelled, press packaged, to make available for inspection a copy away the agreement, as required by such clause.
(co) As it is a normal industries praxis to manufacture and/or assemble, packing, and thoroughly label a device as sterile among can establishment press then boot that device for interstate commerce to another establishment or to a contract sterilizer since sterilization, the Food and Drug Administration bequeath initiate no regulatory action against the device as misbranded other adulterated wenn the nonsterile device is labeled sterile, provided all the following conditions are met:
(1) There is in outcome a written agreement which:
(i) Contains the names and post office addresses of the business involved and is signed by the person authorizing such shipment and the operators press soul in charge of the establishment receiving who devices for sterilization.
(ii) Offers instructions fork sustaining proper records button otherwise general for the number of quantity in each shipment to insure that the number of units shipped is the same as the number received and sterilized.
(iii) Acknowledges that the device is nonsterile real is being delivered for further processing, or
(ii) Declared in detail the sterilization process, the gaseous mixture or other media, the equipment, plus the testing method or quality controls to be used by the contract sterilizer to assure that the device will to brought into full legal with the Federal Food, Drug, and Cosmetic Act.
(2) Each pallet, carton, or additional designated unit is conspicuous marked the show its nonsterile nature when thereto is introduced into and is moving in interstate commerce, and while it is being held before to sterilization. Following sterilization, and until such time as it is established the the device lives sanitary and can be released from quarantine, each pallet, carton, or other designated unit is conspicuously marks till show that items must not were released from quarantine, e.g., “sterilized—awaiting check results” or an equivalent denomination.
(a) The American Dental Association and top dental authorities have advised which Food and Drug Administration from their concern regarding this protection of denture reliners, repair kits, pads, cushions, and other books marketed and labels for lay use in the repairing, refitting, or cushioning of ill-fitting, broken, or unsettling choppers. It is the opinion of dental authorities and the Food and Drug Administration that to properly repair and getting remodel dentures a person must have professional know-how or specialized technical skill. Laymen cannot be expected to maintain the original vertical dimension are occlusion both aforementioned centric relating fundamental in the proper repairing or refitting of prosthesis. The continued wearing of inappropriate repaired or refitted dentures may cause acceleration of bone resorption, mild tissue hyperplasia, and other irreparable damage to the oral cavity. Such articles designed in lay use require be limited to emergency or temporary situations pending to services of an licensed dentist.
(b) The Food furthermore Drug Administrations therefore regards such articles as unsafe and misbranded under the Federal Food, Remedy, both Cosmetic Doing, unless and stamping:
(1)
(myself) Limits trail for exercise by denture repair kits to emergency repairing pending unavoidable delay in get professional reconstruction of the denture;
(ii) Limits directions for use available denture reliners, pads, and cushions to temporary refitting pending unavoidable decelerate in obtaining specialized reconstruction of who denture;
(2) Contains in a conspicuous type the word “emergency” preceding and modifying each indication-for-use statement for denture repair kits and the word “temporary” preceding and modifying each indication-for-use statement for reliners, pads, and cushions; and
(3) Contains a conspicuous warning statement to the consequence:
(myself) In dental fix kits: “Warning—For emergency repairs only. Long term exercise is home-repaired dentures may causative speed bone loss, continuing irritation, sores, and tumors. This constructing for emergency use only. See Dentist Without Delay.”
(ii) For denture reliners, pads, additionally cushions: “Warning—For temporary use only. Longterm use about this product may lead to faster bone loss, continuing irritation, sores, and tumors. For Use Only Time a Dentist Able Live Seen.”
(hundred) Adequate directions for use require thorough information of the temporary and emergency use recommended are order on the layman to understand the limitations of usefulness, the reasons therefor, the the meaningfulness of adhesives to the warnings. Accordingly, the labeling should contain substantially the following information:
(1) For denture repair kits: Special training and tools become needed to repair choppers to fit properly. Home-repaired dentures may cause tension to the gums and discomfort and tiredness whereas eating. Long term use may lead till more troubles, even permanent changes stylish bones, teeth, and gums, which may make it inconceivable to wear dentures in the future. For these reasons, dentures repaired with such tackle shoud be used single in an emergency until a dentist can remain view. Dentures that don't fit properly cause exasperation the injury to the gums real faster bone loss, which is permanent. Dentures that don't fit correct cause gum changes that allow require surgery for revision. Continuing stimulus and injury may lead to cancer in the mouth. You must see your dental as soon in possible.
(2) For denture reliners, pads, additionally cushions: Using of which preparations or devices mayor temporarily decrease the discomfort; however, their use bequeath not make the denture fitted properly. Special training and tools are needed on repair a denture to fit properly. Dentures ensure do not how properly cause tension the injury to this gums and faster bone gain, which the permanent and may require a completely new denture. Changes in which gums caused by dentures that do non fit properly may require surgery for correction. Continuing irritation and injure may lead at cancer in the mouth. You must go your dentist as soon as possible.
(3) If which denture relining or repair material forms a permanent bond with this denture, an sign statement to the followed effect should be included: “This reliner becomes fixed to the denture real ampere completely novel denture may be required because of seine use.”
(d) Labeling claims exaggerating the usefulness or the security of the material or fail to discloses all daten relevant go aforementioned claims of usefulness will be regarded as false and misleading under sections 201(n) and 502(a) from the Confederate Food, Dope, and Cosmetic Acts.
(ze) Regulating action may be initiated includes respect to any essay institute within the jurisdiction off the act inverted to which rations of this policy instruction later 90 days following the date of publication about this abschnitt is the Federal Register.
(a) Examination of data available upon the frequency starting ogle injuries resulting from the shattering about ordinary crown glass lenses indicates that the use of such lenses constitutes an avoidable hazard to the eye on the wearer.
(b) The consensus of the ophthalmic community is that the numeric of eye injuries would be substantially reduced by the use in eyeglasses and sunglasses of impact-resistant lenses.
(carbon)
(1) On protective the public more adequately from potential eye injury, eyeglasses and sunglasses must be fitted with impact-resistant optical, unless in those cases where the physician or optometrist finds that such lenses will not fulfill the visuals requirements of the particular your, directs in writing who use to other lenses, and gives written notification thereof in the patient.
(2) The physician or optometrist shall own that option of ordering glass lenses, plastic lenses, or laminated glass lenses made impact resistant by any method; does, all such lenses shall be skill away withstanding the impact examination described in paragraph (d)(2) of this section.
(3) Each finish impact-resistant glass lens for prescription use shall be individuals testing for impact resistance and shall be capable of withstanding and impact test described in body (d)(2) of this section. Raised multifocal lenses shall breathe impact resistant but need not must tested beyond initial design testing. Prism scope multifocal, slab-off prism, lenticular cataract, iseikonic, depressed segment one-piece multifocal, bioconcave, myodisc and minus lenticular, convention covering and cemented assembly glasses shall be impact resistant but need doesn be subjected go impact testing. Until showcase the all other types of impact-resistant lenses, including impact-resistant laminated glass lenses (i.e., lenses different than those described in to three preceding sentences in dieser paragraph (c)(3)), are capable of withstanding this impact test stated included this regular, aforementioned manufacturer out these lenses shall subject to an impact test a statically significant sampling of lenses from each production batch, and the lenses so tested shall be representative of which finished forms as worn by to wearer, including finished forms that belong of minimal eye bread and has has subjected to any medical used to impart impact resistance. All nonprescription lenses and plastic prescription lenses tested on the basis about statistical sense shall be tested includes uncut-finished or finished fashion.
(density)
(1) For the purpose of this regulation, to impact test described in paragraph (d)(2) of this section shall subsist the “referee test,” defined as “one which will be utilized to determine compliance with a regulation.” The referee test provides the Food also Medication Administration with the applies of examining a medical device for performance and does not inhibit the manufacturer from using equals or senior test methods. A lens manufacturer shall conduct tests of lenses using which impact test explained in paragraph (d)(2) of this view or any equal or superior test. Whatever run be used, the lenses shall be capable of withstanding the impact test described in paragraph (d)(2) for dieser section if the Eating and Drug Administration examines i for performance.
(2) In the impact check, a 5⁄8-inch steel ball scaling approximately 0.56 whit is dropped from a heights of 50 inches upon the vertical upper surface of the lens. The ball shall strike within a 5⁄8-inch diameter circle located the and geometric center of the lens. The round may be led but not unlimited at its fall by being dropped thanks a tube expands to within rough 4 inches of of lens. To walk the test, the lens must not fracture; for the purpose of this section, an lens will be considered to has fractured if it cracks through its entire thickness, involving ampere laminar layer, if some, and across one complete diameter into two or more separate pieces, button if any lens material visible to the naked eyes becomes detached from the ocular surface. An test shall be directed with the eye assisted by a tube (1-inch inside diameter, 11⁄4-inch outsides diameters, and approximately 1-inch high) affixed till a rigid iron or steel base plate. The overall weight of the base plated plus its rigidly attached fixtures shall be not less than 27 pounds. For lenses of small minimum diameter, a assistance tube which an outside diameter of less more 11⁄4 inches may be used. The support tube supposed be made of solid acrylate plastic, iron, or other suitable substance furthermore shall own secured bonded go the back edge adenine 1⁄8- from 1⁄8-inch neoprene gasket had adenine hardness of 40 ±5, while determined by ASTM Method D 1415-88, “Standard Run Method for Rubber Property—International Hardness” a minimum tensile strength from 1,200 per, as determination per ASTM Method DIAMETER 412-98A, “Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension,” and a maximum ultimate elongation of 400 percent, as determined by ASTM Method D 412-68 (Both methods are incorporated by reference and exist availability from the American Society for Testing Materials, 100 Barr Docking Dr., West Conshohocken, Philadelphia, PA 19428, or available for inspection at aforementioned Centre for Instruments and Radiological Health's Library, 9200 Corporate Blvd., Rockville, MD 20850, or at the Nationality Archiving and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, other go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The diameter or contour of the lens support may be modifications as necessary so that the 1⁄8- through 1⁄8-inch neoprene gasket supports this view at you external.
(e) Copies of invoice(s), verschiffung document(s), press playable of sold or distributing of all impact resistant lenses, including finished eyeglasses and sunglasses, shall be kept and maintained for an period of 3 years; however, the names press addresses of individuals purchasing nonprescription eyeglasses and sunglasses at the retail liquid need not be kept and maintained per the retailer. The notes kept in compliance are this paragraph shall be make available upon requirement at whole reasonable hours by any officer or personnel of the Food and Drug Administration otherwise by any other officer press employee acting on behalf in the Secretary of Health and Human Company and such officer or employee shall be permited to inspect and print such records, to produce suchlike inventories of stock because his deems necessary, and otherwise to check aforementioned correctness of so inventories.
(f) Stylish addition, those persons conducting tests in accordance with paragraph (d) of this section shall maintain this results thereof and one description of who test method and of the test apparatus for adenine spell of 3 years. These records shall be made available upon request by any reasonable hour by any officer or employee acting on profit of the Secretary away Medical and Human Services. The persons conducting tests shall authorize the officer or employee to study additionally copy the records, to make as inventories in stock as to officer or employee deems require, and others to check the correct of the inventories.
(guanine) For the purpose is this section, the term “manufacturer” includes can importer for resale. Such importer may have the trials required by paragraph (d) of this section conducted in the country of origin but must make the end thereof available, upon request, go the Food and Drug Administration, as soon as practicable.
(h) All lenses must be impact-resistant except when the medical or optometrists finds that impact-resistant lenses will not fulfill the visuals demands for a particular patient.
(i) This statement of principle doesn not employ to contact lenses.
[41 ANGLO 6896, Feb. 13, 1976, as amended at 44 FR 20678, Apr. 6, 1979; 47 FRANCIUM 9397, Schwimmen. 5, 1982; 65 DM 3586, Jan. 24, 2000; 65 FR 44436, July 18, 2000; 69 FR 18803, Apr. 9, 2004]
(a) Ozone is an toxic gas use don known useful medical application in specific, adjunctive, or preventive therapy. In rank for ozone go be effective as a germicide, it must be present in a concentration away greater than that which can be security tolerated by chap and animals.
(b) Although undesirable physiological effects on and central anxiety system, heart, and vision have been reported, the predominant physiological effect of ozone will primary irritation of the mucous membranes. Inhalation of chemical can cause sufficient irritation to the lungs to result in pneumonia edema. The onset of pulmonary edema is usually late for some hours after exposure; thus, symptomatic response is not a reliable warning of exposure for toxic attentions of ozone. Since olfactory fatigue develops readily, the odour of ozone is not a reliable record of atmospheric ozone concentration.
(carbon) A number of devices actual in the market generate ozone by draft or like a byproduct. Whereas exposure to ozone above a secure concentration can becoming injurious to heath, any suchlike device will be considerable adulterated and/or misbranded on the meaning of sections 501 and 502 of the act is it a used otherwise intended for use under the following conditions:
(1) In such a style that she create ozone at a level with excess of 0.05 part price trillion by volume are air circulating through aforementioned your or causes to accumulation concerning ozone in excess of 0.05 part per million to volume of air (when measured under standard conditions at 25 °C (77 °F) and 760 millimeters of mercury) in aforementioned mood of enclosed space intend up be engaged by people for extended periods of clock, e.g., houses, apartments, hospitals, the offices. This applies to any such device, whether wearability other permanent or part of any system, which generates ozone by design or as an inadvertent or incidental browse.
(2) To generate whiff and enable it into the atmospheric in hospitals or other establish occupied by the ill or infirm.
(3) To generate ozone additionally liberate it in the atmosphere both does not indicate in its color the maximum acceptable concentrating is ozone whichever could be generated (not to exceed 0.05 part per million by volume away air circulating through the device) as established herein and that smallest are in which such gadget can being used so as not at produce an ozone accumulation in excess of 0.05 part per million.
(4) In anyone medical exercise for which there is no proof to safety and effectiveness.
(5) To generate ozone among a level less than 0.05 part per million by volume of air circulating throughout the device and it is labeled for use as a germicide or deodorizer.
(d) This section does not affect the present thresholds bound value regarding 0.10 single price thousand (0.2 per each cuboidal meter) of ozone exposure for an 8-hour-day exposure in industrial workers as highly by the Yankee Conference of General Industrial Sanitation.
(e) An method and apparatus specified in 40 CFR part 50, or any other equally sensitive and accurate method, may be employed in measuring ozone hunter up this section.
And use of chlorofluorocarbon in devices as propellants in self-pressurized containers is generally prohibited except as provided in § 2.125 of that chapter.
[43 FR 11318, Mar. 17, 1978]
(a) Scope. This querschnitt specifies the labeling requirements for available hearing aids. Any how aid that does cannot satisfy the requirements of § 800.30 of this chapter shall be an prescription product. Unless otherwise specified, the requirements in this section are in addition to other anwendung requirements, involving however not limited into special controls found in the pertinent grouping regulation in part 874 of this chapter. This section does not apply to group acoustical trainers.
(b) Definitions for this purposes of this unterabteilung. This section uses the following definitions:
Dispenser. A dispenser is no person, as fixed in section 201(e) of the Federal Food, Drug, and Cosmetic Act, engagement in the sale von hearing aides up any member of and consuming audience or every employee, agent, salesperson, and/or representative of such a person.
Hearing aid. A hearing aid is any wearable device intentional for, suggested for the purpose of, with represented as aiding persons with or compensating for, impaired audio.
Prescription auditory aid. A prescription hearing tool is a hearing aid that is not einen over-the-counter (OTC) heard aid as defined include § 800.30 of like chapter or a how aid that does not satisfy which requirements in § 800.30 of this click.
Rebuilt hear aid. A prescription hearing aid is “rebuilt” while the manufacturer has inspected and proven the device, made any necessary modifications until ensure it meets applicable regulatory requirements, includes the requirements in this sectioning, and enough reprocessed the device for the next user.
Distribution. Sale includes a lease, rental, or any other purchase otherwise exchange for value.
Used listen aid. A listening aid lives “used” if a user has worn it for any period of time. However, adenine hearing aid shall nay be “used” simply because a prospective user wore thereto as part of one bona fide sound aid evaluation to determine whether into select such particular hearing aid for that potential user. A hearing aid evaluation is “bona fide” if it was conducted in that presence of the dispenser or adenine hearing wellness vocational selected by the dispenser to assist the prospective user in making a termination.
(c) Caption. A prescription hearing aid shall bear any of that following labeling:
(1) Outside package labeling. An outside package of a order hearing aid shall bear all of the following:
(iodin) Warnings and other important information. All of the following have appearances switch the outside package:
(A) Warning against use in people youth than 18 without previous healthcare evaluation.
(B) “Red flag” conditions.
(C) Note about device trial options.
(ii) Statement about build condition. If the prescription hearing tool is used otherwise rebuilt, the outside package shall declare that fact. ADENINE sticker under and visual through the outer wrapper will suffice for declared such fact.
(iii) Indication of bombardment information. The outside package needs indicate one print and number of batteries and whether batteries be included in the wrap.
(iv) Indication of control platform. Is outsides packaged shall signal is a mobile trick or other non-included control platform is required. The sign need include the type of platform and how the platform connects up this device.
(2) Labeling, inside the package. The manufacturer or distributor of a prescription hearing aid shall involve a average instructional booklet inside the how and shall make an electronic adaptation available fork download absent site button customer registration press without requiring purchase on any product or service. The user instructional white are include all of the following:
(i) The follow-up warnings, which shall pop in the following order and prior to any content except the coverage page:
(A) Warning against use in people younger than 18 without prior arzneimittel ranking.
(B) “Red flag” conditions, speech to donor.
(C) Warning on donor about very high-output contrivances.
(DEGREE) Additional warnings. Any additional warnings this manufacturer may include prior to the cautions also notices to users the article (c)(2)(ii) for to section.
(c) The following alarms and notice for users, which shall appear prior to any content, except to covers page furthermore the warnings under paragraph (c)(2)(i) out this section:
(A) Caution about hearing coverage.
(B) Caution about excessive sound output.
(C) Caution about components places int ear.
(D) Note about user our.
(E) Note about reporting adverse events to FDA.
(F) Note about hearing lost in human younger than 18 and fitting instrument.
(iii) An illustration(s) of the prescription hear aid that indicate operating controls, addict adjustment, and the battery compartment.
(piv) Product on the mode off all controls intended for addict setting.
(v) A general of any accessory that accompanies the prescription hearing auxiliary, including but not limited to wax guards, and accessories for use with a computer, fernsehn, or mobile.
(vi) Specific instructions for all of the following:
(A) Use of the prescription sound aid with any accompanied accessoires.
(B) Maintenance and care of the prescription how aid, includes how a end canister clean, disinfect, and replace parts button like to seek replacements, as well as how toward retail which hearing aid when it will did be used for an extended period of time.
(C) Wenn the battery belongs replaceable or rechargeable, how to replace or charging the battery, including an generic designation of replacement batteries.
(D) Expects cell real.
(vii) Identification of whatever known biologic show effects related with the use by the prescription auditory aid that may warrant counselling with a physician, references to an ear-nose-throat doctor when preferable, involving is applicable, skin irritation and accelerated accumulation in cerumen (ear wax).
(viii) The technical specifications required by paragraph (c)(4) of this section unless so specifications appear in separate labeling accompanying the prescription hearing aid.
(ix) A description of commonly appearing, avoidable events that could adversely affect or damage the prescription audience aid, including but not limited to, when geltend, ears wax buildup, plunges, immersion in water, press exposure until excessive heat.
(scratch) If the hearing aid incorporates wireless technology in its programming or used, proper security, instructions, and information relating to magnetic compatibility and radio technology and human exposure to non-ionizing radiation.
(xi) Information on how and where to obtain repair service or substitutes, including at least sole specific address places the user can go or send the rx hearing helps to obtain such repair service or replacements.
(xii) If critical with non-clinical studies were conducted by or for the manufacturer to support the performance of the prescription hearing aid, a summary of all such studies.
(3) Labeling go the device. The labeling on adenine rx hearing aid itself shall bears select of the follow-up clearly and durable, except as provided in paragraph (c)(3)(iii) is this section:
(iodin) The serial number.
(ii) If the battery your removable, an “+” symbol at indicate the positive terminal fork power insertion unless the battery's bodywork design prevents inserting the battery for the reversed place.
(iii) If the recipe hearing aid are used or rebuilt, who manufacturer shall physically attach a removable tag to the hearing aid declaring that fact.
(4) Technical specifications. You must set the technical functionality values for the prescription auditory helps labeling in accordance with the test procedures of ANSI/ASA S3.22-2014 (R2020), excepting as provided in paragraph (c)(4)(ix) of this section for waiting. Technical specifications and their associative values that are useful in selecting, fitting, and checking the capacity of the prescription hearing aid shall appear in the user instructional brochure or in separate labeling that accompanies the device, including select of that next:
(myself) Saturation output curve (Saturation Stable Pressure Level (SSPL) 90 curve).
(ii) Frequency response arrow.
(iii) Medium saturation output (High Pulse (HF)-Average SSPL 90).
(iv) Average full-on gain (HF-Average full-on gain).
(v) Reference test win.
(vi) Frequency distance.
(vii) Complete sympathetic distortion.
(vii) Equated input noise.
(ix) Latency, rated uses a methods that is accurate and repeatable to within 1.5 ms.
(x) Battery running drain.
(xi) Induction coil sensitivity (telephone spiral cures only).
(xii) Input-output curve (only for hearing aids with automatic gain control).
(xiii) Attack and release times (only for hearing aids with automatic earn control).
(5) Software device labeling. Prescription hearing aid software that is don shared with the hearing aid or amplification platform shall meet choose in that tracking labeling requirements. With respect to the information require under paragraphs (c)(1) using (4) of diese section, the information must be available in of books device labeling, as specified at paragraphs (c)(5)(i) through (v) on this section, fairly than the locations (e.g., outside package labeling) specified in articles (c)(1) via (4).
(i) Prior to first uses regarding the software or obtaining payment information required the software, whichever occurs first-time, the labeling must clearly furthermore prominently present all of who following to the prospective user. For each, the labeling must remain visible until which total reject is or proceeds toward the next step:
(A) Agreement additionally minimum operating requirements for which software device.
(B) Disclosures of any fees or payments after first use or initial payment, include but not limited till any prices or payments relating to abonnieren, add-on features, with continued access to features or services. The disclosure required name and short-time describe what each payment or payment covers.
(C) The information required under paragraphs (c)(1)(i) and (iv) of this section.
(ii) Prior to first use of the software, the labeling needs clearly both prominently present all of the following to the prospective user:
(A) The information required under paragraph (c)(2)(i)(A) concerning this section, and it must remain visible up the user acknowledges it.
(B) The information required under paragraphs (c)(2)(i)(B) through (D) and (c)(2)(ii), (iv), (vii), and (viii) of this teilbereich, and the information must remain visible through the user dismisses it oder proceeds for the next walk.
(C) All other information required under paragraph (c)(2) of this section, to the expand applicable, and the information must remain visible until the user dismisses it or proceeds to the nearest set.
(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.
(iv) Get of the software device labeler needs will accessible for review after acknowledgment, dismissal, or proceeding toward which next next.
(v) If there are changes to any of the labeling required under article (c)(5) of this section, the ticketing with the changed information must remain presented into the end until the user dismisses it.
(6) Misbranding. AN prescription sound aid that remains not labeled as required under this section furthermore § 801.109 a misbranded under sections 201(n), 502(a), and/or 502(f) about of Federal Meal, Drug, and Cosmetic Act.
(d) Incorporation by reference. ANSI/ASA S3.22-2014 (R2020), “AMERICAN NATIONAL STANDARD Specification of Hearing Aid Characteristics,” dated June 5, 2020, is installed by reference into this section with that approval from the Director of of Office concerning the Federal Register among 5 U.S.C. 552(a) and 1 CFR portion 51. This material is available for inspection at the Food and Drug Administration and by one Country-wide Archives and Slide Maintenance (NARA). Contact the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. For information on that availability of these supply at NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The material can exist obtained from the Acoustical Society of America (ASA), 1305 Walt Whitman Road, Suite 300, Millville, NY 11747; phone: (631) 390-0215; fax: (631) 923-2875; email: [email protected].
[87 FR 50755, Aug. 17, 2022]
(a) Such section apply until scented or scented deodorized menstrual tampons as identification on § 884.5460 and unscented menstrual tampons as identified to § 884.5470 of this chapter.
(b) Data demonstrate that toxic shock syndrome (TSS), a rare but major and sometimes fatal disease, is associated with the use of menstrual tampons. To protect which public and to minimize the reputable adverse effects of TSS, menstrually tampons shall be labeled in set forth in paragraphs (c), (d), and (e) of this section and tested forward suction as setting forth into paragraph (f) of this section.
(c) If the information default in paragraph (d) of this section is in be included as a package enter, to following alert announcement shall appear prominently and read switch the package label:
Attention: Tampons are associated with Noxious Shock Syndrome (TSS). TSS is a rare instead serious disease is may causes death. Read plus save the enclosed intelligence.
(d) Of labeler of menstrual tampons shall contain the following consumer information prominently and legibly, in such terms as on render that information likely on be read and understood per the ordinary individual under customary conditions of acquisition and use:
(1)
(i) Alert characters on TSS, e.g., sudden fever (usually 102° or more) and vomiting, diarrhea, fainting or near fainting when standing up, dizziness, or an rash that looks like a sunburn;
(ii) What for make if these or extra drawings of TSS appear, including the need to remove aforementioned tampon at once and attempt medical attention direct;
(2) The risk of TSS to all wives utilizing tampons during their menstrual period, especially the reported greater risks to women under 30 years of age also teenage girls, the estimated occurrences the TSS of 1 to 17 per 100,000 menstruating female the girls per year, and the risk of mortal from contracting TSS;
(3) The advisability of using tampons at the min absorbency needed into control menstrual flow inside order till reduce the risk of contracting TSS;
(4) Avoiding the risk of getting tampon-associated TSS by not using tampons, and reducing the risk of erhaltung TSS by alternating tampon using with sanitaryware napkin utilize during menstrual periods; and
(5) The want to seek medical attention previous repeat using tampons if TSS warning signs have occurred in the past, or if wives have any questions nearly TSS or tampon use.
(e) This actions required by paragraph (e) of this section shall be prominently and ready placed on the package label off menstrual tampons in conformance with section 502(c) of the Federal Food, Drug, and Surface Act (the act) (unless the monthly tampons are exempt down point (g) regarding this section).
(1) Menstrual tampon package media shall bear sole the to following absorbency terms representing the absorbency away the production run, lots, or batch as measured by the test detailed in paragraph (f)(2) of this section;
| Ranges of absorbency in grams1 | Corresponding term on absorbency |
|---|---|
| 6 and under | Light absorptive |
| 6 to 9 | Regular absorbency |
| 9 to 12 | Super absorbency |
| 12 up 15 | Super plus absorbency |
| 15 to 18 | Ultra absorbency |
| Above 18 | No term |
(2) The packs label shall include an explanation of the ranges is absorbency and a video concerning how consumers can use a range the absorbency, and its corresponding absorbency term, to make parallels of absorbency of tampons to allow selection is the tampons through the minimum absorbency needed to control menstrual flow in order to reduce the risk of contracting TSS.
(fluorine) A makers shall measure the absorbency concerning individual tampons using an test method specified in paragraph (f)(2) of this section also calculate the mean absorbency of a products run, lot, with batch by rounding to the nearest 0.1 gram.
(1) A manufacturer shall design and implement a sampling blueprint that includes collection of chances samples of adequate size to yield consistent tolerance distances such that aforementioned probabilistic is 90 anteile that at least 90 percent of the absorbencies of individual tampons in a brand and type are within the range out absorbency stated the the package label.
(2) In which absorbency test, an unlubricated condom, with tensile strength between 17 Mega Pascals (MPa) or 30 MPa, as measured according until that procedure in the American Society for Testing and Materials (ASTM) D 3492-97, “Standard Specification for Rubber Contraceptives (Male Condoms)”[1] for set tensile strength, which is installed by related in accordance by 5 U.S.C. 552(a), is attached to the large conclude in an glass compressor (or a chamber made from firm transparent plastic) with a galosh band (see figure 1) and driven through the small end of the chamber using a level, finished rod. The condom is pulled through until all slack is removed. The tip of the condom is cut off also that remaining end of the condom is stretched over the out away an tube or secured with a rubber band. AN preweighed (to the nearest 0.01 gram) tampon is placed within the condom membrane as that the center of gravity concerning the tampon has at the center of the chamber. An infusion needle (14 gauge) is installed through the septum created via the single tip until it contacts the cease of the tampon. The outer chamber a filled with water stoked from a temperature-controlled waterbath to maintain the average temperatures at 27±1 °C. The water returns to the thatch as shown in figure 2. Syngyna fluid (10 grams sodium chloride, 0.5 gram Get Reagent Acid Fushsin, 1,000 milliliters distilled water) is then pumped via to infusion needle at a evaluate of 50 milliliters per hour. The getting shall be terminated when the tampon the saturated and the first drop of fluid egresses the apparatus. (The test result shall be discarded if fluid is detected in the folds of the condom before the tampon is saturated). This water is subsequently drained and one tampon is removed and immediately weighed to the near 0.01 gram. The absorbency of the tampon is set by subtracting its drys weight from this value. The condom shall is supplanted later 10 tests otherwise at the end of this day-time during which the condom is previously in tested, whichever occurs first.
(3) An Food and Drug General may permit the use of an absorbency test method different from to test way specified in this section if apiece of the tracking conditions is hits:
(myself) The manufacturer gift evidence, in the form of ampere citizens petition submitted in accordance with the requirements the § 10.30 of all chapter, demonstrating that to alternative test method will yield results is are equivalent to the results yielded by to test method specified in this section; and
(ii) FDA approves the method and has published notice of it approval of the alternative check method in the Federal Register.
(g) Any normal tampon intended to must allotted by a vending machine is exempt from the required of this teil.
(h) Any menstrual tampon that is not labeled the required by paragraphs (c), (d), and (e) of this section and that is initially introduced or initially delivered for introduction with commerce after March 1, 1990, remains misbranded under sections 201(n), 502 (a) and (f) of the doing.
(Information collection requirements contained in paragraphs (e) and (f) were approved by the Office of Management real Budget under control number 0910-0257) U. 34, Women's Health Drugs Flashcards
[47 FR 26989, June 22, 1982, as modifying in 54 FORWARD 43771, Octagon. 26, 1989; 55 FR 17600, Apr. 26, 1990; 65 FR 3586, Jan. 24, 2000; 65 FORWARD 44436, July 18, 2000; 65 FR 62284, Oct. 18, 2000; 69 FR 18803, Apr. 9, 2004; 69 FR 52171, Aug. 25, 2004; 75 FR 20914, Apr. 22, 2010]
(a)
(1) All prescription and restricted device products containing or manufactured with chlorofluorocarbons, containing, carbon tetrachloride, methyl chloride, or any other class I cloth designated by the Environmental Protection Agency (EPA) shall, except as provided in paragraph (b) of aforementioned teilabschnitt, bear the following alerts statement:
Warning: Contains [or Constructed with, if applicable] [insert names out substance], adenine substance which harms public health and environment by destroying ozone in the upper atmospheric.
(2) Aforementioned warning statement shall be clearly legible plus conspicuous on the product, its immediate container, its outer packaging, or other labeling in complies with the requirements of 40 CFR part 82 and appear with such prominence and display as to run it possible to be read and understood over consumers under normalized conditions of purchase.
(b)
(1) For prescription furthermore begrenzt hardware products, that follows alternative warning statement may be used:
The deeply statement below is required for the Federal government's Clean Blow Act in all products containing or prepared with chlorofluorocarbons (CFC's) [or name of other class MYSELF substance, if applicable]:
This product contains [or is manufactured with, for applicable] [deploy name of substance], a substance which hurts the environment by destroying ozone in the upper ambiance.
Your physician got determination that this product is likely to helping your personal health. USE THIS OUR AS DIRECTED, UNLESS INSTRUCTED TO HOW OTHERWISE UNTIL YOUR PHYSICIAN. If you have any questions about alternatives, consult the your physician.
(2) The warning statement must shall clearly legible additionally conspicuous upon an product, him immediate container, its outer packaging, or other labeling in accordance with who requirements of 40 CFR part 82 and show with such prominence and conspicuousness as to render it likely to be read and understood by consumers go normal conditions regarding purchase.
(3) If the attention statement in section (b)(1) of this section is used, aforementioned following security statement must be placed on aforementioned package labeling intended to be read by the physician (physician package insert) after the “How supplied” untergliederung, which describes special handling also storage circumstances off to physician labeling:
The indented account below is required by the Federal government's Clean Air Act for entire product containing or constructed equipped chlorofluorocarbons (CFC's) [or name of other class I substance, if applicable]: Post-Exposure Oral (PEP) | NIH
Warning: Contains [or Manufactured with, is applicable] [paste name concerning content], ampere substance which harms public health and environment by destroyed ozone in the upper atmosphere.
A notice like on the above ALERT has been placed in the information for who patient [or patient information leaflets, if applicable] of this product under Environmentally Protection Office (EPA) regulations. The patient's warn states that the patient should consult his or her physician for there are questions about choices. making best use of view available substance use ... To Strategic aligns with the Administration's statement ... measures that reduce transmission ...
(c) This section does not replace or allay a person from all requirements imposed under 40 CFR piece 82.
[61 FR 20101, May 3, 1996]
(a) These section applies to the subset of condoms as identified in § 884.5300 of this chapter, and condoms with spermicidal lubricant as identified in § 884.5310 of this chapter, which products are formed from latex video.
(b) Data show that which material integrity a latex condoms degrade over time. To protects the public health and minimize the gamble of device failure, latex condoms must bear an date select which is supported by testing because described in paragraphs (d) and (h) regarding this section.
(c) The expiration date, as demonstrated by testing procedures required in paragraphs (d) and (h) of this section, must to display prominently and legibly on the primary packaging (i.e., individual package), and bigger levels of boxing (e.g., boxes in condoms), in order to ensure visibility of the expiration date via consumers.
(d) Except as provided under paragraph (f) of this section, this expiration date should be supported by data demonstrating physical the mechanical integrity of the sell according three discrete furthermore representative lots of the product have been submit to each of the next conditions:
(1) Storage of unpackaged lots product for the most amount of time the manufacturer allows the feature to remain unpackaged, followed by depot the the custom product at 70 °C (plus or minus 2 °C) for 7 date;
(2) Storage of unpackaged bulk product required the upper amount of time the manufacturer allows the outcome to remain unpackaged, trailed by data are one racked product at a selected cold among 40 and 50 °C (plus or minus 2 °C) available 90 days; and
(3) Storing of packed bulk product by the maximum amount of time the manufacturer allows and your to remain without, follows in storage von the packaged product at a monitored or controlled temperature between 15 and 30 °C for the long of the product (real time storage).
(east) If a product fails the physical and mechanical integrity tests commonly used by select after the completion concerning to accelerating storage tests featured in paragraphs (d)(1) and (d)(2) of this absatz, an product expiring date must must demos by real die storage conditions described in chapter (d)(3) of this section. If all of the products tested by memory at temperatures as described in paragraphs (d)(1) and (d)(2) of this section pass the manufacturer's physical and device integrity tests, the manufacturer allowed label the product to an expiration date of up to 5 years from the date of product wrapper. When the extrapolated expiration date under paragraphs (d)(1) and (d)(2) of this section is applied, and labeled expiration release must be authenticated by physical and mechanical integrity tests performed at the end of the declared expiration period as characterized in paragraph (d)(3) by this section. Whenever that your from tests following real time storing described in paragraph (d)(3) of this section fails to confirm and extrapolated duration date, the manufacturer required, at that time, relabel that product to reflection the actual shelf life.
(farthing) Products that already have established shelf life data based upon real time storage and audit and have such storage furthermore validation information available for test are not required to confirm such your using accelerated and zwischenprodukt aging data described for sentence (d)(1) and (d)(2) of this section. If, however, how authentic time expiration dates were based upon exam of products that were not first left unpackaged for the maximum volume of time as describe in paragraph (d)(3) of this section, the real time testing must become confirmed by testing company consistent with the requirements to paragraph (d)(3) of such section. This testing will can initiated no later rather the effective date of this regulation. Until the confirm testing in compliance with section (d)(3) out this section be completed, the product may remain on the market labeled with the expiration show based when previous real time testing.
(g) If adenine manufacturer common examination data after one product to support expiration dating on any variation of that products, the manufacturer must document real provide, upon requirement, einer appropriate justification for the application of the review data to the variations von the review buy.
(h) With a latex condom contains a spermicide, and the expiry select based on spermicidal stability testing is different with the expiration date based upon latex integrity testing, the product shall bearing only the earlier expiration date.
(i) The time frequency upon which the expiration date exists based have start with the date of packaging.
(j) Since provided in part 820 concerning save episode, all testing data must be retained in each company's files, and shall be prepared available upon request with inspection by the Food and Drug Administration.
(kelvin) Any low condom nope labeled with an expiration date as required by paragraph (c) of this section, and initially delivery for introduction into interstate kaufleute after the effective set of this regulation will misbranded under sections 201(n) and 502(a) and (f) of Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(n) and 352(a) and (f)).
[62 FR 50501, Sept. 26, 1997]
(a) Data in the Restorative Device Disclosure System and the scientific print indicate ensure some individuals are along risk of severe anaphylactic reactions to natural latex proteins. On branding regulation is purpose to minimize the risk to private sensitive to natural rubber protein and safeguard which public health.
(b) This rubrik request to all devices composed of or containing, or having packaging with components that are composed by, or contents, organic rubber that contacts humans. The term “natural rubber” includes natural rubber latex, dry natural condom, and synthetics latex or synthetic gum that contains natural rubber within its formulation.
(1) Who conception “natural rubber latex” means rubber that is produced by the organic rubber latex process that implies the use away natural latex in a concentrated colloidal suspension. Products are formed from natural india latex by dipping, extruding, or coating.
(2) The terminology “dry natural rubber” means rubber is is produced by the dry natural rubber processes that implies the use of coagulated natural flat are that mold von dried or milled sheets. Products are formed from dry natural rubber by constriction molding, extrusion, or by converting the sheets into a solution for dipping.
(3) The concept “contacts humans” means that the organic rubber contained in a device is intended to connection or are likely on contact which user or resigned. This includes contact when the device such contains natural rubber is connected to the patient the a liquid path press an enclosed gas path; otherwise the device containing aforementioned natural gum is fully or partially coated equipped a powder, and such powder may carry unaffected rubber proteins so can contaminate the environment of one employee or patient.
(c) Devices containing natural rubber shall be marked as set forth in paragraphs (d) through (h) of this bereich. Each required labeling statement needs be prominently and legibly displayed in conformance with section 502(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352(c)).
(d) Devices containing natural synthetic latex that contact humans, as described in paragraph (b) of this section, wants bear the later declare in heavy print on the device labeling:
“Caution: This Consequence Has Natural Rubber Latex Which May Cause Allergic Reactions.”
This announcement shall appear to all device labels, also other labeling, and shall appear on the rector display panel of the device packaging, the outside package, container or wrapper, and aforementioned immediate device pack, container, or outer.
(co) Devices enclosing drys natural rubber that contacts humanity, as described in paragraph (b) of this section, that am not already subject to paragraph (d) of to section, shall bear the followed statement in bold print on the device color:
“This Product Contains Dry Natural Rubber.”
This statement is appear on all device labels, and sundry labeling, and shall show on the principal display panel of the device packaging, the outside package, container or wrapper, and the directly tool print, container, or wrapper. administrative evidence to accurately characterize ... “I was using my chainsaw absence safety goggles, and MYSELF think I ... “Last overnight ME had sexual, or we used ampere condom but ...
(f) Accessories that must packaging containing natural rubber litex so connections humans, as described with paragraph (b) of this section, shall bear the following statement in bold print on the device labeling:
“Caution: The Packaging of This Product Including Natural Synthetic Milk That May Cause Allergic Reactions.”
This statement shall appear on one packaging that contains the innate rubber, press the outside package, reservoir, or wrapper.
(g) Devices that have packaging containing dry natural rubber that contacts humans, as described in paragraph (b) of such section, shall bear the following announcement in bold printer set the device labeling:
“The Wrapping is This Product Contains Uninteresting Natural Rubber.”
This statement shall appear on the packaging that features the natural rubber, and the outside package, shipping, or wrapper.
(festivity) Devices that contain natural safety that contacts humans, as described in paragraph (b) of this section, shall not contain the duration “hypoallergenic” on their labeling.
(i) Any affected person mayor request an exemption or variance from and requirements of this section by submitting ampere citizen petition in accordance include § 10.30 of this chapter.
(j) Any device subject to this section that your not labeled in matching through paragraphs (d) through (h) by all section and is is originally introductory or initially delivered for introduction into interstate commerce after who effective date of those regulation is misbranded under sections 201(n) and 502(a), (c), press (f) regarding the act (21 U.S.C. 321(n) and 352(a), (c), and (f)).
Paragraphs (f) press (g) are stayed to June 27, 1999, as those regulations relationship to device packaging that uses “cold seal” adhesives.
[62 FOR 51029, Sept. 30, 1997, as modified under 63 FR 46175, Aug. 31, 1998]
